Horizon Pharma plc Files Patent Infringement Lawsuits Against Five Companies for Filing Abbreviated New Drug Applications for PENNSAID(R) (Diclofenac Sodium Topical Solution) 2%

DUBLIN, IRELAND--(Marketwired - Jul 6, 2015) - Horizon Pharma plc (NASDAQ: HZNP), a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced it has filed patent infringement lawsuits in the United States District Court for the District of New Jersey against Actavis Laboratories UT, Inc., Actavis, Inc., and Allergan plc (collectively "Actavis"), Amneal Pharmaceuticals, LLC ("Amneal"), IGI Laboratories, Inc. ("IGI"), Lupin Ltd. and Lupin Pharmaceuticals, Inc. ("Lupin"), and Taro Pharmaceuticals USA, Inc. and Taro Pharmaceutical Industries, Ltd. (collectively "Taro") related to Abbreviated New Drug Applications filed with the U.S. Food and Drug Administration to market a generic version of PENNSAID® (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%).

The lawsuits claim infringement of Horizon's newly issued U.S. Patent No. 9,066,913 titled "Diclofenac Topical Formulation," which covers PENNSAID 2%. These lawsuits are the second patent litigations filed against these defendants relating to PENNSAID 2%.

About PENNSAID® 2%
PENNSAID (diclofenac sodium topical solution) 2% w/w is a non-steroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain of osteoarthritis (OA) of the knee(s). PENNSAID 2% contains diclofenac sodium, an NSAID, and also includes dimethyl sulfoxide (DMSO), a powerful penetrating agent that helps ensure that diclofenac sodium is absorbed through the skin to the site of inflammation and pain. PENNSAID 2% is an alternative to oral NSAID treatment, reducing systemic exposure to a fraction of that provided by the oral NSAID diclofenac. The only topical NSAID offered with the convenience of a metered-dose pump, PENNSAID 2% is applied in two pumps, twice daily, to the site of OA knee pain. For more information, please see www.PENNSAID.com.

IMPORTANT SAFETY INFORMATION

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK

Heart Risk

• Non-steroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious heart clotting events, heart attack and stroke, which can kill you. This risk may increase with longer use. Patients with heart disease or risk factors for heart disease may be at greater risk.
• PENNSAID 2% should not be used if you are in the hospital for certain heart surgeries.

Stomach and Intestine Risk